Coronary Heart DiseaseNCT06172985
A CCTA Image Assisted Triage Software for the Assessment of Patients With Suspected Coronary Artery Disease
An observational study of Coronary Heart Disease, run by Keya Medical at 5 sites in China.
Trial summary
The goal of this clinical trail is to evaluate the effectiveness and accuracy of the CCTA image assisted triage software(DeepVessel® Cardisight, Keya Medical.) for the triage of patients with suspected coronary artery disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 1,093 participants
- Where
- 5 sitesChina
- Study dates
- 9 May 2023to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Suspected patients with coronary heart disease.
Who may be able to join
- CCTA images acquired by CT detectors need to meet the following requirements:
- Check Modal = CT
- Number of detector rows ≥ 64 rows
- Layer thickness ≤1mm
- Layer spacing ≤1mm
- Pixel pitch ≤ 0.5mm
Show all 9Show fewer
- Ball tube voltage ≥ 70kV
- Number of layers ≥ 100 layers
- CCTA image quality score ≥ 3 (5-point Likert scale).
Who cannot join
- Severe coronary artery calcification, which in the judgment of readers affects the stenosis adjudicator;
- Previous percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG);
- Congenital anomalies of coronary artery origin or other malformations;
- Coronary artery occlusive lesions;
- Implantation of the pacemaker, internal defibrillator electrode, or prosthetic heart valve.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
The Pearl River Hospital of Southern Medical University
Guangzhou, Guangdong
Huanggang Central Hospital
Huanggang, Hubei
The First Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou
About this study
Official title: A CCTA Image Assisted Triage Software for the Assessment of Patients With Suspected Coronary Artery Disease: a Retrospective, Multi-center, Blind-evaluation Study
The goal of this clinical trail is to evaluate the effectiveness and accuracy of the CCTA image assisted triage software(DeepVessel® Cardisight, Keya Medical.) for the triage of patients with suspected coronary artery disease.
Read the detailed description
The CCTA images collected by each center within a certain period of time would be screened, desensitized, and then evaluated by the software and independent expert group respectively, to evaluate the effectiveness and accuracy of the coronary CT angiography image stenosis assisted triage software developed by Koyal Medical Technology Co.
Experiment group: Evaluated by the software Independent expert group: Evaluated by experts (≥5 years of CCTA experience required)
- Conditions
- Coronary Heart Disease
- Being tested
- No intervention
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Due to observational study
| Study group | Role | What they receive |
|---|---|---|
| Suspected patients with coronary heart disease. | The coronary CT angiography (CCTA) images collected by each center within a certain period of time will be desensitized after the screening is successful. The final CCTA images were sent to an independent judgment expert group for diagnosis, the results of the test group and the independent judgment expert group were compared, and the clinical application of the coronary artery CT angiography image vascular stenosis auxiliary triage software developed by Keya Medical Technology Co., Ltd. was evaluated. Validity and Accuracy Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of experiment group in triage for patients with suspected coronary artery disease
Based on the results of the independent expert group, uses stenosis degree≥50% as the boundary for triage indication on a per-patient basis.
Measured: October 13,2022 to March 1,2023
Secondary outcomes (12)
Diagnostic time
Independent expert group: recording the sum of image post-processing time (T1) and the time to produce the results (T2); Experimental group: recording the time from image post-processing to outputting results; Calculate the difference between the two groups.
Measured: October 13,2022 to March 1,2023
Patient as research unit
Evaluation criteria were established based on the results of the independent expert group to evaluate the total conformity rate, KAPPA value, positive predictive value (PPV) and negative predictive value (NPV) of triage tips for patients with suspected coronary heart disease in the experimental group.
Measured: October 13,2022 to March 1,2023
Blood vessels were used as the research unit
Evaluation criteria were established based on the results of the independent expert group to evaluate the total conformity rate, KAPPA value, positive predictive value (PPV) and negative predictive value (NPV) of triage tips for patients with suspected coronary heart disease in the experimental group.
Measured: October 13,2022 to March 1,2023
The vascular segment was used as the research unit
Evaluation criteria were established based on the results of the independent expert group to evaluate the total conformity rate, KAPPA value, positive predictive value (PPV) and negative predictive value (NPV) of triage tips for patients with suspected coronary heart disease in the experimental group.
Measured: October 13,2022 to March 1,2023
Gender stratified statistics, respectively, with patients and blood vessels as research units
Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease
Measured: October 13,2022 to March 1,2023
Manufacturer stratified statistics, respectively, with patients and blood vessels as research units
Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease
Measured: October 13,2022 to March 1,2023
Row number stratified statistics, respectively, with patients and blood vessels as research units
Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease
Measured: October 13,2022 to March 1,2023
The stratified statistics of tube voltage were conducted with patients and blood vessels as research units
Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease
Measured: October 13,2022 to March 1,2023
Layer thickness stratified statistics, patients and blood vessels were used as research units
Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease
Measured: October 13,2022 to March 1,2023
The patients and blood vessels were selected as the research units
Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease
Measured: October 13,2022 to March 1,2023
Post-processing image quality evaluation
Calculate the percentage of post-processing images with the image quality score of 2 or above in the total post-processing images, and the difference between the independent expert group and experimental group.
Measured: October 13,2022 to March 1,2023
Software performance evaluation
From the function of use, ease of operation, stability to evaluate, divided into satisfactory, general, unsatisfactory three levels.
Measured: October 13,2022 to March 1,2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start9 May 2023
- Primary completion8 Jun 2023
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 1,093 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keya Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bin Lu, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172985
- Sponsor's protocol ID
- CT-091-2022
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meijboom WB, Meijs MF, Schuijf JD, Cramer MJ, Mollet NR, van Mieghem CA, Nieman K, van Werkhoven JM, Pundziute G, Weustink AC, de Vos AM, Pugliese F, Rensing B, Jukema JW, Bax JJ, Prokop M, Doevendans PA, Hunink MG, Krestin GP, de Feyter PJ. Diagnostic accuracy of 64-slice computed tomography coronary angiography: a prospective, multicenter, multivendor study. J Am Coll Cardiol. 2008 Dec 16;52(25):2135-44. doi: 10.1016/j.jacc.2008.08.058.
PubMed 19095130Lucke C, Foldyna B, Andres C, Boehmer-Lasthaus S, Grothoff M, Nitzsche S, Gutberlet M, Lehmkuhl L. Post-processing in cardiovascular computed tomography: performance of a client server solution versus a stand-alone solution. Rofo. 2014 Dec;186(12):1111-21. doi: 10.1055/s-0034-1366726. Epub 2014 Aug 14.
PubMed 25122171Choi AD, Marques H, Kumar V, Griffin WF, Rahban H, Karlsberg RP, Zeman RK, Katz RJ, Earls JP. CT Evaluation by Artificial Intelligence for Atherosclerosis, Stenosis and Vascular Morphology (CLARIFY): A Multi-center, international study. J Cardiovasc Comput Tomogr. 2021 Nov-Dec;15(6):470-476. doi: 10.1016/j.jcct.2021.05.004. Epub 2021 Jun 12.
PubMed 34127407Paul JF, Rohnean A, Giroussens H, Pressat-Laffouilhere T, Wong T. Evaluation of a deep learning model on coronary CT angiography for automatic stenosis detection. Diagn Interv Imaging. 2022 Jun;103(6):316-323. doi: 10.1016/j.diii.2022.01.004. Epub 2022 Jan 26.
PubMed 35090845Meyer M, Schoepf UJ, Fink C, Goldenberg R, Apfaltrer P, Gruettner J, Vajcs D, Schoenberg SO, Henzler T. Diagnostic performance evaluation of a computer-aided simple triage system for coronary CT angiography in patients with intermediate risk for acute coronary syndrome. Acad Radiol. 2013 Aug;20(8):980-6. doi: 10.1016/j.acra.2013.02.014. Epub 2013 Jun 2.
PubMed 23735619Chen Y, Yu H, Fan B, Wang Y, Wen Z, Hou Z, Yu J, Wang H, Tang Z, Li N, Jiang P, Wang Y, Yin W, Lu B. Diagnostic performance of deep learning-based coronary computed tomography angiography in detecting coronary artery stenosis. Int J Cardiovasc Imaging. 2025 May;41(5):979-989. doi: 10.1007/s10554-025-03383-0. Epub 2025 Mar 29.
PubMed 40156689
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A CCTA Image Assisted Triage Software for the Assessment of Patients With Suspected Coronary Artery Disease: a Retrospective, Multi-center, Blind-evaluation Study
- ClinicalTrials.gov ID
- NCT06172985
- Acronym / sponsor ID
- CT-091-2022
- Conditions
- Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,093 participants (actual)
- Lead sponsor
- Keya MedicalIndustry (pharma, biotech, devices)
- Study start
- 9 May 2023 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trail is to evaluate the effectiveness and accuracy of the CCTA image assisted triage software(DeepVessel® Cardisight, Keya Medical.) for the triage of patients with suspected coronary artery disease.
Detailed description
The CCTA images collected by each center within a certain period of time would be screened, desensitized, and then evaluated by the software and independent expert group respectively, to evaluate the effectiveness and accuracy of the coronary CT angiography image stenosis assisted triage software developed by Koyal Medical Technology Co.
Experiment group: Evaluated by the software Independent expert group: Evaluated by experts (≥5 years of CCTA experience required)
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected patients with coronary heart disease. | – | Other: No interventionThe coronary CT angiography (CCTA) images collected by each center within a certain period of time will be desensitized after the screening is successful. The final CCTA images were sent to an independent judgment expert group for diagnosis, the results of the test group and the independent judgment expert group were compared, and the clinical application of the coronary artery CT angiography image vascular stenosis auxiliary triage software developed by Keya Medical Technology Co., Ltd. was evaluated. Validity and Accuracy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Suspected patients with coronary heart disease.
Key inclusion criteria (9 listed)
- CCTA images acquired by CT detectors need to meet the following requirements:
- CCTA image quality score ≥ 3 (5-point Likert scale).
Key exclusion criteria (5 listed)
- Severe coronary artery calcification, which in the judgment of readers affects the stenosis adjudicator;
- Previous percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG);
- Congenital anomalies of coronary artery origin or other malformations;
- Coronary artery occlusive lesions;
- Implantation of the pacemaker, internal defibrillator electrode, or prosthetic heart valve.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionDue to observational study | Other | Suspected patients with coronary heart disease. |
Primary outcome
Sensitivity and specificity of experiment group in triage for patients with suspected coronary artery disease
Time frame: October 13,2022 to March 1,2023
Based on the results of the independent expert group, uses stenosis degree≥50% as the boundary for triage indication on a per-patient basis.
12 secondary outcomes
Diagnostic time
Time frame: October 13,2022 to March 1,2023
Patient as research unit
Time frame: October 13,2022 to March 1,2023
Blood vessels were used as the research unit
Time frame: October 13,2022 to March 1,2023
The vascular segment was used as the research unit
Time frame: October 13,2022 to March 1,2023
Gender stratified statistics, respectively, with patients and blood vessels as research units
Time frame: October 13,2022 to March 1,2023
Manufacturer stratified statistics, respectively, with patients and blood vessels as research units
Time frame: October 13,2022 to March 1,2023
Row number stratified statistics, respectively, with patients and blood vessels as research units
Time frame: October 13,2022 to March 1,2023
The stratified statistics of tube voltage were conducted with patients and blood vessels as research units
Time frame: October 13,2022 to March 1,2023
Layer thickness stratified statistics, patients and blood vessels were used as research units
Time frame: October 13,2022 to March 1,2023
The patients and blood vessels were selected as the research units
Time frame: October 13,2022 to March 1,2023
Post-processing image quality evaluation
Time frame: October 13,2022 to March 1,2023
Software performance evaluation
Time frame: October 13,2022 to March 1,2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Results publication: PubMed 19095130Meijboom WB, Meijs MF, Schuijf JD, Cramer MJ, Mollet NR, van Mieghem CA, Nieman K, van Werkhoven JM, Pundziute G, Weustink AC, de Vos AM, Pugliese F, Rensing B, Jukema JW, Bax JJ, Prokop M, Doevendans PA, Hunink MG, Krestin GP, de Feyter PJ. Diagnostic accuracy of 64-slice computed tomography coronary angiography: a prospective, multicenter, multivendor study. J Am Coll Cardiol. 2008 Dec 16;52(25):2135-44. doi: 10.1016/j.jacc.2008.08.058.
- Results publication: PubMed 25122171Lucke C, Foldyna B, Andres C, Boehmer-Lasthaus S, Grothoff M, Nitzsche S, Gutberlet M, Lehmkuhl L. Post-processing in cardiovascular computed tomography: performance of a client server solution versus a stand-alone solution. Rofo. 2014 Dec;186(12):1111-21. doi: 10.1055/s-0034-1366726. Epub 2014 Aug 14.
- Results publication: PubMed 34127407Choi AD, Marques H, Kumar V, Griffin WF, Rahban H, Karlsberg RP, Zeman RK, Katz RJ, Earls JP. CT Evaluation by Artificial Intelligence for Atherosclerosis, Stenosis and Vascular Morphology (CLARIFY): A Multi-center, international study. J Cardiovasc Comput Tomogr. 2021 Nov-Dec;15(6):470-476. doi: 10.1016/j.jcct.2021.05.004. Epub 2021 Jun 12.
- Results publication: PubMed 35090845Paul JF, Rohnean A, Giroussens H, Pressat-Laffouilhere T, Wong T. Evaluation of a deep learning model on coronary CT angiography for automatic stenosis detection. Diagn Interv Imaging. 2022 Jun;103(6):316-323. doi: 10.1016/j.diii.2022.01.004. Epub 2022 Jan 26.
- Results publication: PubMed 23735619Meyer M, Schoepf UJ, Fink C, Goldenberg R, Apfaltrer P, Gruettner J, Vajcs D, Schoenberg SO, Henzler T. Diagnostic performance evaluation of a computer-aided simple triage system for coronary CT angiography in patients with intermediate risk for acute coronary syndrome. Acad Radiol. 2013 Aug;20(8):980-6. doi: 10.1016/j.acra.2013.02.014. Epub 2013 Jun 2.
- Derived from this study: PubMed 40156689Chen Y, Yu H, Fan B, Wang Y, Wen Z, Hou Z, Yu J, Wang H, Tang Z, Li N, Jiang P, Wang Y, Yin W, Lu B. Diagnostic performance of deep learning-based coronary computed tomography angiography in detecting coronary artery stenosis. Int J Cardiovasc Imaging. 2025 May;41(5):979-989. doi: 10.1007/s10554-025-03383-0. Epub 2025 Mar 29.
- Guerbet. Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography (X-ACT)\[EB/OL\]Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Lu principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Keya Medical at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of experiment group in triage for patients with suspected coronary artery disease (time frame: October 13,2022 to March 1,2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06172985, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023; AzTrials last refreshed its copy on 31 Oct 2026.